WHO

The much awaited WHO ethics advisory group on the use of experimental drugs to combat Ebola has issued its statement. While a start it is no more than a baby step.

The advisory panel did decide that they found the case for using experimental drugs in African populations ethical. While they did not say much about why they reached this conclusion it seems valid in that when facing a deadly plague the overwhelming majority of people infected would want a drug, even one that has barely been tested, to try to save themselves or a family member. In reaching this conclusion the committee puts to rest the argument that experimental drugs could not go to Africans at all or ought to go to Americans or Europeans first in order to avoid the charge of exploitation. In a plague that kills 90% of its African victims complaints about unwarranted exploitative research seem a bit ridiculous even against a long history of misuse and abuse of poor desperate persons in poor African nations.

The committee did not say a good deal more other than that informed consent and choice ought to be respected. This is far less helpful.

Somewhere between the 20th century Bank ATM and the 25th century Tricorder, lays the EMR that we should have today.

Somewhere between the government-designed Meaningful Use EMR and the Holographic doctor in Star Trek, there should be a long stretch of disposable trial-and-error cycles of technology, changing and morphing from good to better to magical. For this to happen, we must release the EMR from its balls and chains. We must release the EMR from its life sentence in the salt mines of reimbursement, and understand that EMRs cannot, and will not, and should not, be held responsible for fixing the financial and physical health of the entire nation. In other words, lighten up folks …

A patient’s medical record contains all sorts of things, most of which diminish in importance as time goes by. Roughly speaking, a medical record contains quantifiable data (numbers), Boolean data (positive/negative), images (sometimes), and lots of plain, and not so plain, English (in the US).

The proliferation of prose and medical abbreviations in the medical record has been attacked a very long time ago by the World Health Organization (WHO), which gave us the International Classification of Disease (fondly known as ICD), attaching a code to each disease. With roots in the 19th century and with explicit rationale of facilitating international statistical research and public health, the codification of disease introduced the concept that caring for an individual patient should also be viewed as a global learning experience for humanity at large. Medicine was always a personal service, but medicine was also a science, and as long as those growing the science were not far removed from those delivering the service, both could symbiotically coexist.

In 2007-8, when counterfeit versions of heparin, a blood-thinning drug, were shipped from China to the United States market, 149 people died. In the last few months, bogus versions of the cancer drug Avastin, apparently shipped from the Middle East, have surfaced in clinics in California, Illinois and Texas. Thankfully, so far as we know, they haven’t killed anyone, but more and more cases of dangerous fake drugs are being reported by the Food and Drug Administration. Numerous incidents surely go unreported, the evidence swallowed, the deaths incorrectly attributed to natural causes.

Fighting the fake-drug menace is like playing whack-a-mole. It is technically illegal for individuals to order drugs online from other countries. And yet no sooner does the F.D.A. shut down one dubious online pharmacy than another pops up. According to the National Association of Boards of Pharmacy, only 3 percent of the 9,600 online pharmacies it has reviewed complied with industry standards. Many were based overseas, so their sales to Americans were illegal; others did not require doctors’ prescriptions. And some were very likely peddling dangerous counterfeit drugs.

In the fall of 2009, at the height of fears over swine flu, our research group discovered that a majority of clinical trial data for the anti-influenza drug Tamiflu ― data that proved, according to its manufacturer, that the drug reduced the risk of hospitalization, serious complications and transmission ― were missing, unpublished and inaccessible to the research community. From what we could tell from the limited clinical data that had been published in medical journals, the country’s most widely used and heavily stockpiled influenza drug appeared no more effective than aspirin.

After we published this finding in the British Medical Journal at the end of that year, Tamiflu’s manufacturer, Roche, announced that it would release internal reports to back up its claims that the drug was effective in reducing the complications of influenza. Roche promised access to data from 10 clinical trials, 8 of which had not been published a decade after completion, representing more than 4,000 patients from every continent except Antarctica. Independent verification of the data seemed imminent. But more than two years later, and despite repeated requests, we have yet to receive even a single full trial report. Instead, the manufacturer released portions of the reports, most likely a very small percentage of the total pages. (One of us, Tom Jefferson, has been retained as an expert witness in a lawsuit relating to some of these issues.)

The case for leapfrogging ICD-10 and holding out for ICD-11 just got a lot more curious. And though it’s not here yet, when ICD-11 is ready, it will be something ICD-10 cannot: A 21st Century classification system.

Now that HHS Secretary Kathleen Sebelius has thrown her department’s hat in the ring, saying late Wednesday that HHS intends to delay ICD-10, the most pertinent question is how long will HHS push back compliance?

“My opinion is that CMS won’t be able to announce three months or six months of delay for ICD-10,” says Mike Arrigo, CEO of consultancy No World Borders (pictured at left). “They will need to announce a delay from October 1, 2013 to at least October 1, 2014 because of CMS fiscal planning calendars.”

Others in the industry are suggesting that even one year is not enough to lighten the burden on physicians, providers and payers enough to make the transition smoother.

“I have a gut feeling they’ll go for two years, who knows?” speculates Steve Sisko, an analyst and technology consultant focused on payers and ICD-10. “Maybe January 2015?”

“We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead,” Sebelius said in the statement. “We are committing to work through the rulemaking process, with the provider community, to reexamine the pace at which HHS and the nation implement these important improvements to our healthcare system.”

Dr. Len over at the American Cancer Society is raising legitimate questions about the early release of findings by the World Health Organization’s International Agency for Research on Cancer (IARC) that cell phone use may increase the risk of brain cancer (hat tip to Gary Schwitzer’s HealthNewsReview). The actual study — drawn from an analysis of “hundreds of scientific articles ” — won’t be published in Lancet Oncology “for a few days,” according to IARC. Says Dr. Len:

Unfortunately, drawing broad and sweeping conclusions based on a press release and a news conference leaves many of us wondering just what the evidence shows that led to the conclusion announced today that “radiofrequency electromagnetic fields” may be possibly cause cancer in people.

The evidence, when it appears, will be murky. A few years ago, I spent several months reviewing some of the evidence in this troubling field, largely from a conflict-of-interest perspective. The global telecommunications industry funds much of the science. Even when government agencies fund research, the results are difficult to interpret. The studies invariably involve looking for a very small number of negative health outcomes (brain cancers) in very large populations. Two researchers, looking at the very same set of epidemiological facts, will often come to different conclusions. And, as often as not, those conclusions correlate with whether the the researchers are independent or whether they are on industry’s payroll. Continue reading “The Role of Conflicted Science in the Cell Phone-Cancer Link”

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